Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diclofenac sodium
Discovery Pharmaceuticals
M01AB05
Diclofenac sodium
75mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5060029400040
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. − If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET 1. What FENACTOL 75MG SR and FENACTOL RETARD 100MG are and what they are used for 2. What you need to know before you take FENACTOL 75MG SR or FENACTOL RETARD 100MG 3. How to take FENACTOL 75MG SR or FENACTOL RETARD 100MG 4. Possible side effects 5. How to store FENACTOL 75MG SR and FENACTOL RETARD 100MG 6. Contents of the pack and other information 1. WHAT FENACTOL 75MG SR AND FENACTOL RETARD 100MG ARE AND WHAT THEY ARE USED FOR Diclofenac sodium, the active ingredient in FENACTOL 75MG SR and FENACTOL RETARD 100MG tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. FENACTOL 75MG SR and FENACTOL RETARD 100MG tablets are especially formulated to release the diclofenac sodium slowly. FENACTOL 75MG SR and FENACTOL RETARD 100MG tablets relieve pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles and tendons including: • Rheumatoid arthritis, osteoarthritis, acute gout (painful inflammation of the joints especially in the feet and hands), ankylosing spondylitis (form of spinal arthritis). • Backache, sprains and strains, soft tissue sports injuries, frozen shoulder, dislocations and fractures • Conditions affecting the tendons for example, tendonitis, tenosynovitis, bursitis. They are also used to treat pain and inflammation associated with dental and minor surgery. FENACTOL 75MG SR and FENACTOL RETARD 100MG tablets are not suitable for childr Lire le document complet
OBJECT 1 FENACTOL 75 MG SR Summary of Product Characteristics Updated 02-Jan-2018 | Discovery Pharmaceuticals 1. Name of the medicinal product Dicloflex 75 mg SR and Fenactol 75 mg SR (own-label name for Whatdrug Ltd. T/A Discovery Pharmaceuticals Ltd.) 2. Qualitative and quantitative composition Diclofenac sodium 75 mg Excipients(s) with known effect For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged-release tablet . Pink, round, biconvex tablet, marked "DICL 75" on one side. 4. Clinical particulars 4.1 Therapeutic indications ADULTS AND ELDERLY Relief of all grades of pain and inflammation in a wide range of conditions, including: (i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, (ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis, (iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery. CHILDREN Diclofenac Sodium 75 mg prolonged-release tablets are not suitable for children. 4.2 Posology and method of administration Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). _ADULTS:_ One tablet once or twice daily The recommended maximum daily dose of diclofenac sodium is 150mg. _SPECIAL POPULATIONS_ _ELDERLY:_ Although the pharmacokinetics of Diclofenac sodium are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight (see also precautions) and the patient should be monitored for GI bleeding during NSAID therapy. _RENAL IMPAIRMENT: _Diclofenac is contraindicated in patie Lire le document complet